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510(k) Data Aggregation

    K Number
    K982016
    Device Name
    PIPER IPPB MODEL 2055
    Manufacturer
    VORTRAN MEDICAL TECHNOLOGY 1, INC.
    Date Cleared
    1998-11-03

    (148 days)

    Product Code
    NHJ
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in delivering intermittent positive pressure aerosol treatment on patients with a body weight greater than 30 kg (adults).

    Device Description

    Piper IPPB™ Model 2055

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indication for Use" statement for the Piper IPPB™ Model 2055. It does not include any information about acceptance criteria or a study proving that the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailing performance studies and their acceptance criteria.

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